APIC 原料药亚硝胺风险评估报告模板-2025年2月英文对照版).docxVIP

研究报告

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APIC原料药亚硝胺风险评估报告模板-2025年2月英文对照版)

一、Introduction

1.PurposeoftheReport

TheprimarypurposeofthisreportistosystematicallyevaluatethepotentialrisksassociatedwiththeformationofN-nitrosaminesinactivepharmaceuticalingredients(APICs).Thiscomprehensiveassessmentaimstoprovideaclearunderstandingofthesources,mechanisms,andconsequencesofN-nitrosaminecontaminationinAPICs,whicharecrucialforensuringpatientsafetyandregulatorycompliance.Thereportwillserveasavaluableresourceforstakeholdersinvolvedinthepharmaceuticalindustry,